LivaNova’s Perceval Sutureless Aortic Heart Valve Approved in Japan
Jun. 11, 2018
LONDON--(BUSINESS WIRE)--Jun 11, 2018--LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, today announced that Japan’s Ministry of Health, Labour and Welfare has approved the Company’s Perceval ® sutureless aortic heart valve to treat aortic valve disease.
“With this approval for Perceval, an innovative and trusted valve platform, we are able to provide patients and clinicians in Japan with a new option for aortic heart valve replacement,” said Noriaki Kawana, President, LivaNova Japan.
The Perceval sutureless valve is supported by a strong body of evidence with more than 10 years of clinical experience. The valve is specifically designed to reduce the physiological impact of aortic valve replacement and improve patient outcomes. Perceval is also designed to be highly versatile and suitable for a wide range of surgical approaches, including traditional and minimally invasive.
“At LivaNova, we are committed to enhancing patient care around the world, and will continue to address the increasing global need for advanced aortic valve solutions,” said Roy Khoury, President, LivaNova International.
LivaNova obtained CE Mark for Perceval in 2011 and U.S. Food and Drug Administration approval in 2016. To date, more than 25,000 patients worldwide have been treated with the Perceval valve.
LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. LivaNova’s advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems. Headquartered in London, LivaNova has a presence in more than 100 countries worldwide. The Company currently employs more than 3,500 employees. LivaNova operates as two businesses: Cardiac Surgery and Neuromodulation, with operating headquarters in Mirandola (Italy) and Houston (U.S.A.), respectively.
Safe Harbor Statement
This news release contains forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended. Forward-looking statements are not historical facts but are based on certain assumptions of management and describe LivaNova’s future plans, strategies and expectations. Forward-looking statements can generally be identified by the use of forward-looking terminology, including, but not limited to, "may," “could,” “seek,” “guidance,” “predict,” “potential,” “likely,” "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or variations of these terms and similar expressions, or the negative of these terms or similar expressions. Forward-looking statements contained in this news release are based on information presently available to LivaNova and assumptions that LivaNova believes to be reasonable, but are inherently uncertain. As a result, LivaNova’s actual results, performance or achievements may differ materially from those expressed or implied by these forward-looking statements, which are not guarantees of future performance or actions that may be taken by LivaNova and involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond LivaNova’s control. You should carefully consider the risks and uncertainties that affect LivaNova, including those described in the “Risk Factors” section of LivaNova’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents filed from time to time with the United States Securities and Exchange Commission.
All information in this news release is as of the date of its release. LivaNova does not undertake or assume any obligation to update publicly any of the forward-looking statements in this news release to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable law. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. We caution you not to place undue reliance on any forward-looking statements, which are made only as of the date of this news release.
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CONTACT: LivaNova PLC Investor Relations and Media
Karen King, +1 (281) 228-7262
Vice President, Investor Relations & Corporate Communications
Deanna Wilke,+1 (281) 727-2764
Director, Corporate Communications – Products & Therapies
KEYWORD: UNITED KINGDOM EUROPE ASIA PACIFIC JAPAN
INDUSTRY KEYWORD: SURGERY HEALTH CLINICAL TRIALS MEDICAL DEVICES OTHER HEALTH RESEARCH FDA SCIENCE
SOURCE: LivaNova PLC
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PUB: 06/11/2018 09:00 AM/DISC: 06/11/2018 09:02 AM